Augmented delivery catheter and method

ABSTRACT

The present invention relates to a catheter apparatus with an anchoring device to stabilize the catheter tip when in use, such as when infusing, injecting, or delivering substances, devices or other catheters into a patient. The apparatus according to various embodiments deploys an anchoring device that stabilizes the catheter tip and enables adjustment of the blood flow during use.

CROSS REFERENCE TO RELATED APPLICATIONS

This present application is a continuation application of U.S. patentapplication Ser. No. 16/407,712, entitled “AUGMENTED DELIVERY CATHETERAND METHOD”, filed May 9, 2019, now abandoned, which is a continuationapplication of U.S. patent application Ser. No. 14/807,359, entitled“AUGMENTED DELIVERY CATHETER AND METHOD”, filed Jul. 23, 2015, now U.S.Pat. No. 10,335,577, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/111,924, entitled “AUGMENTED DELIVERY CATHETERAND METHOD”, filed May 19, 2011, now U.S. Pat. No. 9,126,016, whichclaims the benefit of U.S. Provisional Patent Application No.61/395,907, entitled “AUGMENTED DELIVERY CATHETER AND METHOD”, filed onMay 19, 2010, and U.S. Provisional Patent Application No. 61/400,593,entitled “DEVICES AND METHODS OF TREATING VENOUS DISEASE”, filed on Jul.30, 2010, the entire disclosure of each of which is incorporated byreference herein.

FIELD OF THE INVENTION

This disclosure relates to a catheter with an anchoring device tostabilize the catheter tip when in use, such as when infusing,injecting, or delivering substances, devices or other catheters into apatient.

BACKGROUND OF THE INVENTION

Catheter technology is widely utilized to diagnose many abnormalities,to treat vascular disease, to perform vascular interventions, to deliverdevices to occlude vessels, and to focally deliver agents to tissues,among other uses. The catheter technology employed will vary dependingon the surgical procedure and the nature and extent of the injury. For ageneral background on catheter technology and some of the tools andapparatus used involving catheters, see U.S. Pat. No. 5,910,150 issuedto Saadat on Jun. 8, 1999 (“Saadat”), the entire disclosure of which isincorporated herein by reference in its entirety. In addition, furtherbackground on catheter technology and some of the tools and apparatusused involving catheters is found in U.S. Pat. No. 7,241,257 issued toAinsworth et al. on Jul. 10, 2007 (“Ainsworth”), the entire disclosureof which is incorporated herein by reference in its entirety.

Some attempts have been made to develop catheters useful and adaptablefor multiple applications, see U.S. Pat. No. 5,632,754 issued to Farleyet al. on May 27, 1997 (“Farley”), the entire disclosure of which isincorporated herein by reference in its entirety.

Many times the stability of the catheter tip is not problematic orcritical to the procedure, but routinely the stability of the cathetertip is indeed important to the success of the particular procedure. Inmany cases a “guide” catheter is inserted and the tip is placed withinor near the orifice of the vessel intended to be treated. See forexample U.S. Pat. No. 5,947,995 issued to Samuels on Sep. 7, 1999(“Samuels”), the entire disclosure of which is incorporated herein byreference in its entirety.

The interventional device catheter of choice, whether it is anangioplasty balloon catheter, a stent delivery device, an atherectomydevice, or some other specialized catheters, is then placed coaxiallythrough the guide catheter to effect the desired intervention. In thecase of coronary angioplasty, stent placement, or other intervention,the guide catheter frequently “backs out” of the coronary orifice when aguide wire or the interventional device catheter is advanced through thenarrowed lesion, or attempts are made to advance through the narrowedlesion, because of the resistance caused by the lesion. For a generalbackground on stenting and guiding catheters, see U.S. Pat. No.7,645,296 issued to Theron et al. on Jan. 12, 2010 (“Theron”), theentire disclosure of which is incorporated herein by reference in itsentirety.

This results in repeated attempts to cross the lesion, change thecatheter/guide wires, predilation with a smaller catheter, reinsertionof the original catheter, and so forth, and adds additional risk andcost to the procedure. In the case of chronic total occlusions (CTO's),the crossing of the CTO can be extremely difficult as there is acomplete occlusion without a lumen that provides resistance to thepassage of the guide wire and interventional device. Moreover, sincethere is no lumen in CTO's, there is a need to center the lumen of thecatheter within the lumen of the vessel to lessen the chance ofsubintimal dissections by the guide wire. In other words, aneccentrically positioned guide wire has a greater chance of trackingsubintimally along the outer circumference of a vascular lumen than doesa guide wire positioned centrally within the lumen.

Similarly, in the endovascular treatment of carotid artery lesions, theacute angles, especially at the origin of the left common carotidartery, create difficulty in advancing the stent delivery catheters asthe guide catheters tend to back out of the orifice when the stentdelivery catheters are advanced.

This results in repeated attempts at positioning the catheters, changingthe catheters, and added risk and cost to the procedure. The risk ofstroke increases with the difficulty of the procedure.

In fact, the same type of problem occurs with regularity anywhere in thebody in which a catheter or guide wire is attempted to be pushed througha tight stenosis. The resistance of the stenotic lesion, along with thecurvature of the arteries, prevent enough forward force or “pushability”to advance the interventional devices through the lesion easily. Mostvascular catheterizations are done with a percutaneous approach throughthe femoral artery or vein. As will be shown, in the arterial system,the catheters must then take a circuitous route through the aortic archto access most any vessel supplying the head and neck, upper extremity,and the heart. The vessels in the abdomen branch in an acute angle (withrespect to the femoral approach) making them difficult to access also.While the vessels of the lower extremity may be approached with anantegrade puncture in the ipsilateral femoral artery, accessing andtreating them may present similar problems as above if the access isdone from the contralateral femoral artery. In sum, there is veryinfrequently a vessel that is subjected to an endovascular interventionof any type in which there is a more or less straight line of force toplace and advance the catheter tip from the femoral access point. Theresulting forces are frequently not in the direction of the cathetertip, causing the catheter tip's purchase within the selected vessel tobe tenuous, especially since the heart is contracting and the aorta ispulsating. The combination of the tortuous path the catheters must take,the resistance within the vessel caused by vessel tortuosity or theconstricted lesion, and the pulsations of the heart and the aortacombine to make vascular interventions more difficult, more costly, andmore risky to the patient than is generally perceived.

Different catheter shapes and configurations have been developed toaccess problematic arteries, but frequently the choice of a specializedshape is made only after repeated attempts to catheterize an artery orto perform an intervention within an artery have failed. Sometimes ashape is chosen which is successful in catheterizing an artery, but theinterventional device cannot be passed through the catheter or guidecatheter to the lesion without dislodging the guide catheter. Pushingthe inner catheter against tortuous vessels or a tight stenotic lesionessentially pushes the guide catheter out of the orifice of the vessel.The difficulties described above in the current procedures and devicesare overcome, as discussed, by changing out the catheters, using othermethods and devices, albeit at increased cost and risk, to achieve thedesired result.

In other interventions, substances or devices are injected or deliveredinto certain arteries in which it is critical that the catheter tip isstable and there is no movement at all, less the patient may sufferserious and even fatal sequelae. One of these vascular interventionsinvolves infusing concentrated chemotherapeutic agents directly into anartery supplying an organ to treat tumors within that organ. Thefollowing description involves placing a catheter in the hepatic arteryand serves as an example of the problems associating with delivering asubstance or device into arteries.

There are several methods of treating cancerous tumors includingsurgery, chemotherapy, focal ablation by delivery of various forms ofenergy, radiation, among others. Often, tumors are not resectable bysurgery because they have spread into the surrounding tissue or todistant tissue, such as the liver, lung, or brain. The treatment ofmetastatic disease to these organs is done with chemotherapy, focalsurgical resection, focal ablation and occasionally radiation when thereare only a few lesions. Oftentimes, the metastatic disease is diffusedand not amenable to surgery, radiation or focal ablation. This leaveschemotherapy as the only alternative, and the effectiveness of theintravenous chemotherapy is limited by the systemic toxicities caused bythe drug, including bone marrow suppression, neutropenia, nausea,diarrhea, anorexia, wasting, cachexia, bacterial or viral overgrowthamong others.

Often perfusion of the organ containing the tumor or tumors with achemotherapeutic agent is performed. This may be done by simplyinjecting the chemotherapeutic agent directly into the artery supplyingthe organ, or by chemoembolization in which the chemotherapeutic agentis mixed with or attached to some substance before it is injected. Theinjection may be made into a branch artery that supplies the targetedtumor rather than in the main artery to the organ. This has beenreferred to as selective chemoembolization. Substances mixed with orattached to the chemotherapeutic agent include gelfoam, lipiodal, andother substances. The chemotherapeutic agent may be coated on smallbeads that are embolized to the tumor as drug eluting beads (DEB's.) Thebeads that are embolized may instead carry a radioactive substance, suchas Yttrium 90, a beta emitter. Collectively, methods and substances thatcombine radiation or chemotherapeutic agents with a carrier are termed“embolics.” The selective injection into the branch artery supplying thetumor insures the embolization of the beads, containing eitherchemotherapeutic agent or a radioactive agent, to the tumor bed wherethe beads lodge in small arterioles and the substance attached to thebeads acts upon the tumor over several days to weeks rather than therather passive non-selective method of just injecting a chemotherapeuticagent into the artery which creates only a fleeting contact with thetumor. When the embolics are injected into an artery, they willeventually occlude the arterial branches and the artery, causingdiminished to stagnant flow in the artery. In this case, there is alikelihood of reflux of the emoblics out of the intended artery causingthem to embolize to other unintended arteries and organs. This may causea litany of problems and complications, obviously. It is a purpose ofthe current invention to direct the chemotherapeutic agent orradioactive agent with or without embolics toward the target tumor ororgan, to stabilize the catheter tip in appropriate position and toprevent reflux of the agents out of the intended vessel. Moreover, bycontrolling the flow through the current invention and the pressuredistal to the tip of the device, the pressure distally can be kept lowerthan pressure proximally obviating any reflux.

A system, process, and method of isolated perfusion of organs with avery high dose of a chemotherapeutic agent, collection of the effluentvenous blood from that organ before it enters the systemic circulation,filtering the chemotherapeutic agent from the collected blood, andreturning the filtered blood without the chemotherapeutic agent to thesystemic circulation has been described and has shown greateffectiveness to date in treating tumors of the liver. In essence, avery high dose of a chemotherapeutic agent is infused into the hepaticartery over a period of time, usually from 30 minutes to an hour. Thehigh dose chemotherapeutic agent perfuses the liver and is much moreeffective than a traditional systemic dose administered intravenously.This drug is taken up by the tumor and the remainder flows into thehepatic veins, which are a series of veins that drain from the liverinto the upper inferior vena cava (IVC.) This blood which still containstoxic levels of the chemotherapeutic agent is collected by an isolationdevice which is part of this special apparatus. The hepatic infusioncatheter which is placed percutaneously is usually a standardangiographic catheter. The hepatic venous blood isolation device is adouble balloon system that is deployed in the inferior vena cava, theballoons being inflated above and below the hepatic veins, the hepaticvenous effluent collected into a catheter and pumped through a filteroutside the body that removes the chemotherapeutic agent, and returns tothe superior vena cava via another catheter. A through lumen is providedto allow blood from the inferior vena cava to flow back to the heartwhile the balloons are occluding the vena cava.

While current devices are generally effective in treating the tumor ortumors of the liver, they are somewhat crude and cumbersome to use, asthere sometimes is reflux of the toxic chemotherapeutic agent out of thehepatic artery and into arteries supplying the bowel, and the cathetertip may become dislodged from its place in the proper hepatic artery,retracting more proximally and infusing agent into arteries supplyingthe proximal small bowel, pancreas, spleen, and other organs. This is ofgreat importance as the dose being infused may be up to ten times theusual intravenous dose, and hence can cause serious side effects if notcollected as above before entering the systemic circulation. If it isnot infused into the correct artery, it will not be collected by thevenous recovery device, and this concentrated toxic substance willessentially be a local and systemic poison with which the body is unableto deal. Infusion catheters with a balloon on the distal end have beendescribed, but the balloon must be expanded completely to producestability of the distal catheter and, in doing so, obstructs the flow ofthe vessel and the flow of the infused material. While the currentinvention is described for infusion of a chemotherapeutic agent into theliver, it should be realized that the current invention could beutilized in other organs and regions of the body to infuse any number ofmedicines, substances, agents, particles, occlusive devices, stents,coils, and so forth in those different regions.

Furthermore, in perfusing the liver, the standard angiographic catheterwhich is placed in the hepatic artery usually is inserted via a femoralapproach, traverses the iliac artery and abdominal aorta and then mustbe placed in the celiac axis which is frequently at a 135 degree orgreater angle to the aorta, advanced further into the common hepaticartery, and finally placed with the tip in the proper hepatic arterywhich is a rather short artery. This tortuous path places some torque onthe catheter, and patient motion, whether voluntary or from normalrespiration or vascular pulsations, may cause the catheter tip to backout of the proper hepatic artery during the infusion of thechemotherapeutic agent. This causes the toxic chemotherapeutic agent toflow into vessels other than the intended ones, potentially damagingthose tissues supplied by theses vessels, including the pancreas,duodenum, stomach, and spleen among others. Even if the catheter tipdoes not move and is stable, there is the possibility of reflux of thetoxic agent out of the hepatic artery and into these adjacent arteriesas spasm may develop in the hepatic arteries as a result of the infusionof the chemotherapeutic agent, or the infusion rate may exceed the flowin the hepatic artery for some other reason resulting in the volumebeing infused exceeding the capacity of the artery. The infused agentthen refluxes out of the intended artery and into the surroundingvessels not intended for infusion causing the problems discussed aboveand even death. While the majority of cases of infusions may well besuccessful with the current prior art device, even a small minority ofthe infusion procedures that have complications would give the clinicaloncologists and oncological surgeons who care for these patients concernand raise questions as to whether the procedure is truly safe. Thisdoubt may prevent thousands, and potentially hundreds of thousands, ofpatients that may benefit from this therapy from receiving it andprolonging their lives.

Additionally, in the case of renal cell carcinoma, it is frequentlyadvantageous to embolize coils or other materials into the renal arterybefore a nephrectomy. This creates a more or less bloodless field forthe surgeon and makes the operation easier, safer, and quicker. Itinvolves placing a catheter in the renal artery and delivering a specialcoil or other material to occlude the renal artery. The procedure isusually straightforward. In some cases, however, the catheter tipbecomes dislodged, usually while attempting to place the second or thirdcoil in the renal artery and the coil embolizes down the aorta and intoa lower extremity or other vessel where it must be retrieved bycatheters or by surgery. This is another example of catheter tipinstability causing an iatrogenic complication.

In crossing a chronic total occlusion, sometimes there is a need toapproach the lesion retrograde, or from a downstream location.Frequently the distal aspect of the CTO is easier to enter than theproximal arterial cap for several reasons. In this maneuver, the guidewire is passed from distally in a retrograde manner through the CTO andthen the tip of the guide wire is captured by a snare inserted in astandard antegrade manner and then withdrawn through an antegradecatheter. This maneuver includes engaging the guide wire with the snare,then placing traction on the snare dragging the guide wire into theantegrade catheter and then out the external end of the antegradecatheter. When this is done, the guide wire is usually deformed and bentupon itself. This provides the operator with access that would otherwisenot be possible. The current device placed antegrade upstream of theocclusion, with its funnel shape, could be utilized as a capture deviceto capture the guide wire placed in a retrograde manner through theocclusion. This may be important when the guide wire cannot be capturedby a snare, bent on itself and easily fished out through the standardantegrade catheter. Additional uses of the current invention includecapture of guide wires in any artery or vein, channel of the body, ortract or space, whether natural or surgically created.

Traditional catheter techniques or technologies to prevent or inhibitinstability of a catheter as positioned within a patient can imparttrauma to the patient and/or prevent or severely restrict blood flow.

For example, U.S. Pat. No. 5,078,685 issued to Colliver on Jan. 7, 1992(“Colliver”) provides a vascular catheter with an elongated, flexibletubular catheter body fitted with a rigid tunnel member. The tunnelmember is intended to define an open, non-collapsible, longitudinalpassageway for blood flow outside of the catheter body when the vascularcatheter is inserted in a blood vessel of a patient. However, such arigid collar-like member enables only imprecise degrees of pressure tobe axially imparted to the blood vessel, thereby causing unnecessarytrauma to the patient.

U.S. Pat. No. 6,238,412 issued to Dubrul et al. on May 29, 2001 (“DubrulI”), and U.S. Pat. No. 6,695,858 issued to Dubrul et al. on Feb. 24,2004 (“Dubrul II”), describe a catheter device for removal of a blockagein a passageway such as a dialysis graft or in a body passageway. Thedevice of Dubrul I and II includes a traditional funnel-like catheterfor reception and aspiration of the blockage and an occlusion engagingelement supported on a wire that extends through the catheter. Thedevice includes a braid device that expands against the blood vesselwall to stabilize the catheter and to prevent the occlusion from passingaround the outside of the device; blood flow is also prevented frompassing through the device.

U.S. Pat. No. 6,699,260 issued to Dubrul et al. on Mar. 2, 2004 (“DubrulIII”) describes a catheter device for removal of a blockage in a bodypassageway fitted with a multi-wing malecot expansion device. Similar toDubrul I and II, the Dubrul III device entirely blocks blood flow, andthe targeted blockage, from passing around or through the device.Further, U.S. Pat. Pub. No. 2010/0114113 to Dubrul et al. published May6, 2010 (“Dubrul IV”) discloses a catheter device for occlusion removalthat blocks blood flow.

U.S. Pat. Pub. No. 2004/0260333 to Dubrul et al. published on Dec. 23,2004 (“Dubrul V”) and U.S. Pat. Pub. No. 2010/0030256 to Dubrul et al.published on Feb. 4, 2010 (“Dubrul VI”) describe a collection of funnelcatheters, catheter/dilator assemblies, occluders, and associatedmethods which either entirely block blood flow or do not allow acontrolled, predictable adjustment of allowed blood flow.

The prior art catheters and methods of use do not provide aminimal-trauma device that enables predictable and adjustable blood flowthrough or around a catheter device, prevent reflux as desired, allowcentered and/or directional flow of medicament, or accurate, reliableand stable precise positioning. The device and method of the currentinvention described below addresses these deficiencies and problems, andfurther solves the problem of catheter tip instability which may resultin infusion of a toxic agent unintentionally into surrounding vesselswhile preventing reflux from the desired vessel into the surroundingvessels and tissues even when the catheter tip is stable and otherfactors cause the toxic substance to reflux.

SUMMARY OF THE INVENTION

Certain embodiments of the present disclosure relate to a catheter withan anchoring device to stabilize the catheter tip when in use, such aswhen infusing, injecting, or delivering substances, devices or othercatheters into a patient. The device is comprised generally of a tubularmember configured as a catheter with a distal end comprising an outersheath or tube, an inner sheath or tube, an anchoring mechanism such asa braid with permeable and impermeable portions that enables reliableand stable positioning of the catheter while delivering medicaments (ormedical devices or implements such as stents) while allowing acontrollable level of blood flow and/or reflux. Other embodiments andalternatives to this device are described in greater detail below.

As used in this disclosure, the terms “catheter”, “anchor catheter”, and“device” all refer to one or more embodiments of the invention.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the cathetertechnology and surgical procedures in which catheters are used and tofurther describe the various tools and other apparatus commonlyassociated therewith: U.S. Pat. No. 5,078,685 issued to Colliver; U.S.Pat. No. 6,238,412 issued to Dubrul et al.; U.S. Pat. No. 6,695,858issued to Dubrul et al.; U.S. Pat. No. 6,699,260 issued to Dubrul etal.; U.S. Pat. No. 6,635,068 issued to Dubrul et al.; U.S. Pat. No.5,916,235 issued to Guglielmi; U.S. Pat. Pub. No. 2010/0114113 to Dubrulet al.; U.S. Pat. Pub. No. 2004/0260333 to Dubrul et al.; and U.S. Pat.Pub. No. 2010/0030256 to Dubrul et al.

According to varying embodiments described herein, the present inventionis directed to the use of a catheter to any area of the body foradministering medicaments or medical devices or implements such asstents. However, the invention may be used in any medical applicationwhere it is important to stabilize the distal end of a medical device.Also, the present invention may be used in primary surgery, as well asin revision surgery in which a follow-up procedure is being performed inan area that has previously been subject to one or more surgeries.Further, the invention may be used in any application where material isto be delivered with precision to a confined area where access isrestricted, to include surgical procedures, repair of installed oruninstalled mechanical or electrical devices, and arming or disarming ofexplosive devices. Although many embodiments and example discuss use ofthe device within a human, the device and methods of use may be used inany animal. Also, although many embodiments and examples describe use ofthe device within a blood vessel or other human vessel, the device andmethods of use may be used in any body channel of a human or animal Inaddition, although blood is referenced frequently as the fluid involvedwith the device, any fluid present in a body channel is applicable tothe invention.

Briefly, in one preferred embodiment of the invention, the anchorcatheter device employs an expansile member on the tip of a catheterdesigned to anchor the tip and provide stability while maintaining flowin the vessel, and further to limit and direct flow beyond the cathetertip to obviate reflux. To achieve stability of the catheter tip, aporous tubular mesh braid is attached to the distal aspect of thecatheter in one embodiment. It may be a self expanding braid or it maybe controlled by actuator sheaths which will be subsequently described.The braid expands to the vessel wall and stabilizes the catheter tip bycontacting the wall, essentially anchoring it to the vessel wall by agentle annular force.

According to the present invention, in one embodiment a cathetercomprises an elongated catheter body having a distal end, a proximalend, and an axial lumen therebetween. The catheter also includes ahousing having a hollow interior, an open proximal end, a distal end andan aperture on a lateral side of the housing. A coupling element isprovided for connecting the distal end of the catheter body to theproximal end of the housing. A work element is movably disposed in thehousing and operative through the aperture. A work element connector isdisposed in a lumen of the catheter body, preferably the axial lumen,and has a distal end connected to the work element. The proximal end ofthe connector is available at the proximal end of the catheter body forattachment to a device appropriate for the operation of the workelement.

According to various embodiments of the present disclosure, one aspectof the invention is to provide a catheter device that comprises atubular member which is substantially hollow and that generally has acircular cross sectional shape. However, as one skilled in the art wouldappreciate, the device cross-section need not be limited to a generallycircular shape. For example, cross-sections of an oval shape or thosewith at least one defined angle to include obtuse, acute, and rightangles can provide a shape in some situations that is more congruentwith the size or shape of the particular vessel area. A substantiallyround shape may also be employed that provides the surgeon with anindication of directional orientation.

According to various embodiments of the present disclosure, it isanother aspect that the hollow tubular member further comprises aproximal end and a distal end, whereby the distal end is configured withan outer sheath or tube, an inner sheath or tube, a mesh braid withpermeable and impermeable portions that enables reliable and stablepositioning of the catheter while delivering medicaments (or medicaldevices or implements such as stents) while allowing a controllablelevel of blood flow and/or reflux. The inner sheath or tube fits withinthe outer sheath or tube. The method of use comprises preciselyinserting the anchor catheter into the surgical area. The inner andouter sheaths are then engaged in a controllable manner to deploy ananchoring mechanism. In one embodiment, the anchoring mechanism is amesh braid that is attached to one or both of the inner and the outersheaths. When deployed, the mesh braid imparts a minimal but effectivelevel of axial force against the surrounding vein so as to stabilize thecatheter.

In one embodiment, the mesh braid is fitted with a portion that isimpermeable to flow and a portion that is permeable to blood flow,therein controllably allowing blood flow through the vessel, in additionto controllably allowing reflux, or backflow, of medicament of othersubstances past the catheter tip.

In another embodiment, the device has the general shape of a standardselective angiographic catheter used to access abdominal vesselsincluding the proper hepatic artery. The distal tip of the devicehowever is comprised of an expansile mesh braid. The catheter comprisesan outer sheath coaxially placed over an inner sheath. The two sheathsare moveable relative to the each other serving to expand and collapsethe braid.

In further embodiments, the device includes a locking mechanismrotatably or otherwise attached to the outer sheath which may be fixableto the distal aspect of a hub of the device. When the braid of thedevice is expanded, the inner sheath is advanced into and through theouter sheath causing the locking mechanism to engage the distal aspectof the hub. The two components can be locked together by turning them orby other means. The device may be utilized alone or may be deliveredthrough a guide catheter to the celiac axis. The guide catheter may infact have the same or similar shape and features as the configurationdemonstrated for the infusion or delivery catheter. The guide catheter,for example, may be anchored in the proximal celiac axis, and theinfusion or delivery catheter would pass coaxially through the guidecatheter.

In another embodiment of the invention, the braid of the device isbonded to the distal ends of an inner member and of an outer member. Thebraid is collapsed by withdrawing the inner member with respect to theouter member and expanded against the vessel wall by advancing the innermember with respect to the outer member. When expanded against thevessel wall, the braid will anchor the catheter tip and prevent it frommoving because of patient movement, respiratory movement, or justbecause of the torque caused by the circuitous path traversed from, forexample, the femoral artery to the proper hepatic artery. This will addsignificantly to the safety profile of the procedure. Moreover, animpermeable elastomeric membrane may cover a portion of the mesh braidso that antegrade blood flow occurs about and beyond the catheter tip,but the flow is partially obstructed or limited. This would cause thepressure in the hepatic arteries, for example, distal to the cathetertip to be less than the pressures proximal to the catheter tip, hencethe likelihood of any reflux of infused agent would be markedlydiminished. The elastomeric membrane may be placed on or within the meshbraid at any location to include near the inner member or near the outermember or in the middle, but preferably only covering a portion of thebraid so that flow is maintained. In a preferred embodiment, theelastomeric membrane is placed on or within the mesh braid away from thecatheter tip. This forces the blood to flow through the open portion ofthe braid and just distal to the tip of the catheter. This redirectedflow insures enhanced admixing of the injected agent with the flowingblood. This feature is particularly important, for example, in theproper hepatic artery (which is a rather short artery) and it insuressuccessful perfusion of both right and left hepatic artery branches.

Therefore, by incorporating the expansile mesh braid into the cathetertip, the current invention provides stability of the anchor catheterdevice preventing it from becoming dislodged from its position in, forexample, the proper hepatic artery, and provides for back flow or refluxprevention by partially occluding the vessel while still providing forantegrade flow of blood that will carry the infused agent into the liverand to the tumor it is intended to treat. Enhanced admixing of the agentinsures proportionate delivery of the agent to the branching arteries,especially if anchor catheter tip is positioned in close proximity tothe arterial branches. It is usually desirable to place an anchorcatheter tip in close proximity to the arterial branches to prevent thereflux phenomenon described above, therefore this flow directing featureof the current invention is quite desirable.

In an alternative embodiment, the expansile anchor of the anchorcatheter device is configured as a mesh braid, yet is mounted solely toan inner sheath and not additionally mounted to an outer sheath. In thisembodiment, the expansile anchor is an extension of the distal aspect ofthe inner sheath. When undeployed, the expansile anchor braid is withinthe lumen of the distal tip of the device and is internal to the outersheath. The expansile anchor braid is extended or deployed by movementof the inner sheath away from or distally to the outer sheath. Theexpansile anchor braid self-deploys as the inner sheath is moved furtheraway from the outer sheath; the expansile anchor braid deploys so as torest against the vessel wall and impart a controlled axial force againstthe vessel wall. The expansile anchor braid is configured with apermeable mesh braid portion and an impermeable elastomeric portion. Tocontrol blood flow and pressure distally, the outer sheath is advancedover the permeable mesh braid portion, therein covering at least aportion of the permeable mesh braid portion and thus regulating orthrottling blood flow. This embodiment may provide additionalflexibility to the anchor catheter device.

In another embodiment, the coating of the tubular braid is placed insuch a position that when the pressures distal to the tip become closeto or equivalent with the pressures proximal to the tip, the extrudedtubular braid changes shape somewhat so that even less blood flowsthrough the permeable portions of the tubular braid.

In one embodiment, the device and all of its components are made of thesame material. In another embodiment, the device and its components aremade of different materials, for example, the inner and outer sheathsare made of one type of material, and the anchor braid is made ofanother material.

In one embodiment, the anchor mechanism does not employ an inflatableballoon or similar structure that confines a fluid within a closed spaceto achieve an anchoring function.

In one embodiment, the tubular braid is not a balloon as employed incatheters in the prior art that feature a balloon.

In one embodiment, the mesh braid is fitted with a membrane entirelyimpermeable to flow. Such an embodiment would be particularly usefulafter passing a stent delivery catheter through a lesion and deployingthe stent, wherein the operator may want to aspirate the debris that ispresent to protect the downstream vasculature. In such a configuration,the device would serve as both an anchoring catheter and a proximalembolic protection catheter.

In another embodiment, a separate flap mechanism may be provided thatwould tend to allow forward flow but not reverse flow or reflux. Theflap mechanism extends from within the inner sheath in a generallyfluted-shape, ending in a fluted-bell, that extends past or distally tothe distal tip of the device such that when extended, it has minimal tono effect on the blood flow in the vessel, but when rested against theexpansile braid, restricts or totally prevents blood flow. Thefluted-shape may be either of one continuous material or consist of aplurality of fans so as to, in totality, form a fluted-shape, either byoverlapping with one another or through fitting without overlapping. Theflap mechanism may be configured as other than a fluted shape, toinclude a conical shape. The flap mechanism may be configured as aflower with a plurality of petals. Further, the flap mechanism may bemanipulated and/or deployed/retracted in any of several ways, to includeas an additional, third sheath inner to the inner sheath, or as anintegral part on the inner sheath. Further, the flap mechanism acts as acheck value and is a passive device, wherein the flap mechanism preventsor occludes reverse flow yet allow antegrade that is forward flow.

In another embodiment, to further prevent movement or migration of thedevice during infusion, an attachment mechanism secured to the cathetershaft at or near the skin insertion site may be provided. It may vary inconfiguration from a suture attached to the tissues, to a clip at theskin level, to an anchoring device, or any other means of preventingmovement of the catheter.

In one embodiment, the anchor mechanism is configured with an adhesivemechanism to provide additional stability of the device. For example,the adhesive mechanism may comprise striations, gripping surfaces, or anadhesive material.

In one embodiment, the anchor mechanism is configured with a meshcomprised of materials of variable strength, to include a mesh withelastomeric elements and elastomeric longitudinal elements. Further, themesh may be of various fabric materials.

In other embodiments, the expansile tip of the anchor catheter thatsecures the catheter tip to the wall of the vessel while preserving flowbeyond the catheter tip is accomplished through other means than abraided mesh structure, including, but not limited to stent likestructures, parallel wires, non parallel wires, spiral elements,circular elements, tubular elements, laser cut structures, buddy wires,a malecot device, and any structure or component which expands near thedistal tip of the catheter and secures it while preserving flow isincluded by this mention. Further, the expansile tip may be of any shapethat is extendable or deployable to engage a vessel wall and impartaxial pressure against a vessel wall, to include funnel shapes, umbrellashapes, conical shapes, and ring shapes.

In another embodiment, a catheter apparatus comprises a catheter bodyhaving a proximal portion, the distal portion having an expansile anchormechanism operatively associated therewith, the anchor mechanismcomprising mesh material at least at said distal portion that permitsfluid to flow therethrough, the anchor mechanism having a firstunexpanded configuration and a second expanded configuration, saidsecond expanded configuration bringing said anchor mechanism intocontact with a wall of a body cavity to reversibly anchor the distalportion of said catheter body in said cavity without substantiallyprecluding a flow of fluid within said body cavity. This embodiment mayfurther comprise a multi-petaled member connected to said distal portionthat, when the anchor mechanism is in the second expanded configuration,the multi-petaled member substantially prevents the flow of fluid. Also,this embodiment may further comprise an anchor mechanism that, when inthe expanded configuration, has a balloon-like shape but is devoid ofany structure to confine a fluid.

In another embodiment, a catheter apparatus comprises a first tubularmember comprising a first distal end and a first lumen; a second tubularmember comprising a second distal end and a second lumen, said secondtubular member received within the first lumen of the first tubularmember; and a collapsible anchoring element adapted to be disposedwithin a body cavity across a passage thereto, said anchoring elementhaving a collapsed shape and an extended shape, said collapsed shapebeing generally collapsed longitudinally along an axis of said secondtubular member and expanded generally radially outwards therefrom toanchor said catheter against said body cavity; said first and secondtubular members being connected to each other at their distal ends, andsaid first and second members being longitudinally movable relative toone another to control the movement of the anchoring element between thecollapsed and extended shapes. This embodiment may further comprise ananchoring element that comprises a mesh. This embodiment may furthercomprise an anchoring element comprises an elastomeric.

The methods of utilizing all of the above configurations are quitesimilar. In the case of infusion of a substance into the liver andrecovering the effluent venous blood, filtering out the toxic agent, andreturning it to the body as has been previously described, imagingstudies such as CT scans, MRI, or others are utilized to measure thedistance between the most cephalad placement of the venous recoverycatheter, whether it be the cavoatrial junction or thesupradiaphragmatic IVC, and a point just above the renal veins.Measurements are also taken of the dimensions of the IVC. An appropriatesized recovery device is chosen. A catheter is placed in the properhepatic artery from a femoral puncture for subsequent perfusion of theliver by a concentrated high dose substance. This infusion catheter isusually delivered to the celiac trunk by a guide catheter which may havea special shape for engaging the celiac axis or trunk. It may be theguide catheter described or a standard guide catheter. Further, theanchor catheter may be used as a guide catheter. In many cases, theanchor infusion catheter described above may be used as the infusioncatheter. It is advanced through the guide catheter, through the celiacaxis or trunk, and through the common hepatic artery, and the tip placedin the proper hepatic artery. In the case of the anchor catheter, themesh anchor is deployed stabilizing the catheter tip. The mesh anchormay or may not comprise a partial elastomeric coating which limits flowpast the catheter tip as described previously. The recovery device ofthe current invention, in one configuration or the other, is placed inthe IVC and deployed so that the isolation apparatus covers the hepaticvenous ostia and creates a hepatic venous effluent collection chamber.Testing is done to determine if the placement is appropriate byinjection of contrast in a retrograde manner through the recoverycatheter and into the hepatic venous effluent collection chamber, anddemonstrating that there is no leakage from the isolated segment.Contrast is injected into the distal IVC to determine that there is goodreturn through flow to the right atrium. Hepatic venous effluent will becollected, and the hepatic arterial infusion will begin through thehepatic artery infusion catheter. The venous effluent will be collectedand pumped and filtered and returned as in the prior art devices for aperiod of time. After the arterial infusion is complete, the infusioncatheter will be removed. In the case of the anchor catheter, the distalbraid is collapsed by advancing the inner member with respect to theouter member. The venous effluent collection and treatment will continuefor a prescribed period to prevent any delayed washout of theconcentrated high dose substance from the liver into the systemiccirculation. After a period of time, the chosen recovery device willthen be collapsed, retracted, and removed from the body.

In one method of use of the anchor catheter device, a guide catheterconfigured with the anchor catheter device is placed coaxially over adiagnostic catheter. The diagnostic catheter is then utilized tocatheterize the origin of the selected vessel, whether it be a coronaryartery, a carotid artery, the celiac artery, or any other selectedartery. The guide catheter of the current invention is then advancedover the tip of the diagnostic catheter to a point in the proximalselected artery. The anchor device of the current invention may then bedeployed and the diagnostic catheter removed. The interventionalcatheter, whether it be a stent delivery catheter, an angioplastycatheter, atherectomy device, infusion catheter, or other type ofcatheter, will be advanced coaxially through the guide catheter of thecurrent invention. In the case of tortuous anatomy in the selectedartery, the anchored guide catheter of the current invention supportsthe advancement of the interventional catheter even down tortuous sidebranches and the like. This is of importance in accessing a point forinfusion of a substance or for accessing a lesion distally placed in theselected artery. In the case of a stenotic lesion, the anchored guidecatheter of the current invention supports the advancement of a guidewire through a narrow stenotic lesion, or even through a completeocclusion, and allows subsequent passage of the interventional catheterthrough a narrowed stenotic lesion. Forward pressure on the catheterwill not cause it to dislodge the guide catheter of the currentinvention as that guide catheter is anchored securely within the orificeof the vessel. The problems with the prior art guide catheters are henceobviated, the lesions treated with less effort, less time, less cost,and less risk to the patient.

An additional use of the current invention includes capture of guidewires in any artery or vein, channel of the body, or tract or spacewhether natural or surgically created. In some other vascularinterventions, it may be necessary to capture the tip of guide wire andto externalize the tip through a second puncture site. This can beaccomplished with the current invention by placing the anchor catheterdevice into the artery, vein, or channel at a second and differentlocation than the guide wire was initially placed. Expanding the braidof either embodiment will cause the end of the catheter to becomesomewhat funnel shaped. The guide wire can then be manipulated rathereasily into the funnel shaped end of the catheter of the currentinvention, advanced toward the catheter hub, and advanced out of thecatheter hub so that one end is entering the artery, vein, or channel atthe original puncture site and the second end of the guide wire isexiting the second location. This may be important in performingthrombectomy in the venous system or in performing percutaneous stentgraft placements in which at least a portion of to the stent graft isplaced extraluminally, i.e., not within the artery, vein, or channelthat is being bypassed, or in treating CTO's.

The device and method of the current invention will also solve theproblem of catheter tip or guide catheter tip instability in otherendovascular interventions in the carotid, coronary, renal, celiac,mesenteric and other arteries and veins. There are significant problemsthat can result from these iatrogenically created complications such asdamage to the adjacent or distant organs and tissues and systemiceffects that may create a cascade of events which result in stroke,myocardial infarction, infections, unnecessary surgery, and death amongothers. These complications are the result of the use of the standardangioplasty catheter for delivery of the agent or interventional device.

It is a purpose of this patent application to provide a new device ordevices that will successfully and effectively deliver the concentratedagent or interventional device to the organ of interest without anyreflux or flow into the surrounding adjacent vessels. Specifically, inthe case of focal organ perfusion, the delivery of the agent will beonly to the liver or other organ of interest by stabilizing the cathetertip with a novel catheter tip stabilization device, and preventunintended reflux of the agent even when the catheter tip is stable bycontrolling the flow and pressures distal to the tip of the device. Itis also a purpose of the current invention and method to facilitate thesafe and effective delivery of interventional devices for endovasculartreatments by enhancing the stability of the catheter tip.

In the case of a guide catheter which delivers a second diagnostic orinterventional catheter coaxially through the lumen of the guidecatheter, the catheter tip would be centered within the orifice of thecatheterized artery by the stability device rather than the usuallyeccentric position of the tips of standard prior art guide catheters.This is a secondary benefit, but an important one. The guide catheterwould be centered and anchored to the proximal portion of the arterycatheterized, allowing the interventionalist to more easily pass otherguide wires, catheters, and therapy devices distally into tortuous orpartially occluded arteries. The likelihood of the guide catheterbecoming dislodged from the vessel because of forward advancementpressures would be greatly diminished if not completely obviated. Thisstability of the tip of the guide catheter that prevents movement of thetip is a main function of the current invention. Other catheters couldbe inserted through this guide catheter even if the anatomy wasproblematic, such as an elongated aortic arch, or the distal vasculaturewas problematic from tortuosity or because of a stenotic lesion thatresisted crossing. A catheter utilizing an expandable tubular mesh braidcould also be utilized to deliver coils to occlude a vessel, or othersubstances or structures, especially if the vessel to be treated was nota sub-selective catheterization.

In the case of an infusion catheter, the current invention would securethe catheter tip within the artery and prevent it from becomingdislodged by patient motion, respiratory motion, pulsations within theartery, because of the torque on the catheter secondary to thecircuitous route of the catheter or a combination of the above. Oneembodiment would utilize a tubular mesh braid to expand against the wallof the artery to be infused. This would prevent dislodgement. Further, aportion of the mesh braid in another embodiment would be covered with animpermeable elastomer that would permit blood flow around and distal tothe catheter tip but limit the amount of flow. It would produce apartial obstruction to blood flow in the vessel. By limiting the flow,there would be enough blood flow maintained to carry the infused orinjected substance distally into the branches of the artery and to thetumor, but the pressure distal to the catheter tip would be less thanproximally so that the chance of reflux would be minimized if notobviated. Moreover, the elastomeric material is arranged in such a wayto direct flow to the artery just distal to the catheter tip so thatadmixing of blood and the injected or infused substance is enhanced.This is accomplished by coating the portion of the tubular mesh braidthat contacts the wall and a portion of the most distal tubular meshbraid but leaving the braid adjacent to and surrounding the catheter tipopen. Even further, the construction of the braid and the coating maycomprise elements that regulate the flow depending on pressuredifferences. Hence the current invention with an elastomeric coatingplaced at a specific location on the mesh braid will secure the tip inplace, limit the flow to reduce or eliminate reflux, and enhance theadmixture of blood and the injected substance.

One aspect of the present invention is directed to provision of acatheter that is able to achieve many of the functions of existingballoon catheters, but without the problems associated therewith. Forexample, in late 2010, the FDA has issued a class I recall—the agency'smost serious—for a dilation catheter because the device may crack orbreak, which can result in bleeding or death. Cracks or breaks in theshaft of a Dilatation Catheter—used to dilate arterialstenoses—presented an issue where there was a risk that the balloon mayfail to inflate or deflate, leading to unplanned intravascular or opensurgery, significant vasospasm, prolonged tissue ischemia, tissueinjury, infarct, bleeding, and/or death. As the present invention doesnot employ a balloon to achieve desired anchoring within a blood vessel,such issues are avoided.

The present invention further avoids many issues associated with priorart systems and methods, especially those that employ ballooncatheter-type systems. For example, with respect to balloon cathetersystems, there are problems in creating an accurate and repeatableprocess for pleating and folding long length balloon catheters (up to250 mm) with the smallest possible profile. Prior art system have issueswith the balloon profile, deployment characteristics and ability tore-fold upon deflation may differ greatly from unit to unit. Handfolding of such devices or mechanized folding and pleating systems stillrequire a custom sizing of pleat head to the product specifications tocreate optimized folded balloons with the smallest profile with gooddeployment and re-fold characteristics. Prior art designs require thatfor one to achieve a desired balloon dimension, various processparameters must be attended to, such as but not limited to: diameter,temperature, balloon pressure/vacuum and delay/dwell times, all of whichmust be accurately controlled and subject to machine repeatability. Withpleated balloon systems, it is desirable to have each pleat identical toallow for a uniform expansion. Once deflation is initiated the pleats ofthe balloon material must have sufficient re-fold characteristics toallow the balloon to fold at the locations previously imparted in thematerial allowing for a low extraction profile. All of these issues areavoided by the present invention.

Furthermore, with prior art catheter systems used for bladder issues,the tip of the catheter placed into the bladder has an inflatable“balloon” on the tip, which when inflated prevents the catheter fromslipping out. In some cases, the balloon can tear or break while thecatheter is being inserted through the urethra into the bladder. Inother situations, the balloon may fail to inflate. Such issues areavoided by use of the present system and method as no inflatable balloonis employed. Anchoring is achieved in an entirely distinct fashion thatavoid the problems experienced with prior art balloon systems.

Another aspect of the present invention includes providing an anchorcatheter device which is entirely or partially disposable. The outersheath, inner sheath, and expansile anchor may comprise at leastportions of biocompatible material which can stay in the vessel withoutimpairing the final implantation. Alternatively, it may thus be amaterial that is resorbable, such as a resorbable polymer, in the vesselafter the surgical procedure.

In another embodiment of the invention, the distal end of the anchorcatheter device is in communication via a conduit to enable electrical,hydraulic, pneumatic, or mechanical transmission, the later such as awire. Such hydraulic communication allows, for example, remote orautomated use of the device. Such mechanical communication allows, forexample, the distal end to be maneuvered with further precision.

It is yet another aspect of the present disclosure to provide an anchorcatheter device that contains one or more detachable components.According to various embodiments, these detachable devices may includethe expansile anchor or, for example, a medical device for implantation,such as a stent.

Furthermore, the anchor catheter may be configured to engage with othermedical devices, such other medical devices to include other catheters.For example, in another embodiment of the invention, the anchor cathetermay be attached to the exterior of a long teen indwelling central venouscatheter to anchor the catheter within the soft tissue tunnel as will besubsequently described. It will not only stabilize the long term centralvenous catheter, but will block the tunneled tract or channel so thatthere is no ingress of bacteria that may cause infection.

One skilled in the art will appreciate that the distal end of the anchorcatheter device need not be limited to those specific embodimentsdescribed above. Other forms, shapes or designs that enable theforegoing aspects of the present invention are hereby incorporated intothis disclosure. Forms, shapes and designs that relate to the provisionof an end of an anchoring device fitted to a catheter to perform medicalprocedures are considered to be within the scope of the presentdisclosure.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may have various sizes. The sizes of the variouselements of embodiments of the present disclosure may be sized based onvarious factors including, for example, the anatomy of the patient, theperson or other device operating the apparatus, the catheter insertionlocation, the size of operating site or the size of the surgical toolsbeing used with the device.

One or ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide the various aspects of the presentdisclosure. These materials may include, for example, stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. These materials may also include, for example, PEEK,carbon fiber, ABS plastic, polyurethane, rubber, latex, syntheticrubber, and other fiber-encased resinous materials, synthetic materials,polymers, and natural materials. The anchor catheter elements could beflexible, semi-rigid, or rigid and made of materials such as stainlesssteel, titanium alloy, aluminum alloy, chromium alloy, and other metalsor metal alloys. In certain embodiments, the anchor catheter and/orparticular components are composed of plastic and are intended for oneuse only and then discarded. In another embodiment, some or all elementsof the device, or portions of some or all of the elements, areluminescent. Also, in another embodiment, some or all elements of thedevice, or portions of some or all of the elements, include lightingelements. In another embodiment, the anchor catheter and/or particularcomponents are made of a substantially transparent material and/or arerigidly opaque.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be controlled by means other than manualmanipulation. Embodiments of the present disclosure may be designed andshaped such that the apparatus may be controlled, for example, remotelyby an operator, remotely by an operator through a computer controller,by an operator using proportioning devices, programmatically by acomputer controller, by servo-controlled mechanisms, byhydraulically-driven mechanisms, by pneumatically-driven mechanisms orby piezoelectric actuators.

Embodiments of the present disclosure present several advantages overthe prior art including, for example, the stability and reliabilityspeed of the procedure, the minimally invasive aspect of the procedure,the ability to controllably introduce medicaments (or medical devices orimplements such as stents) to a site with minimal risk and damage to thesurrounding tissue, the lower risk of infection, more optimally placedmedicaments, and fewer tools in a vessel site due to the integration ofseveral components required to provide or deliver medicaments to areceiving area. Further, the prior art does not provide a minimal-traumadevice that enables predictable and adjustable blood flow through oraround a catheter device, prevent reflux as desired, allow centeredand/or directional flow of medicament (or medical devices or implementssuch as stents), or accurate, reliable and stable precise positioning.The device and method of the current invention addresses thesedeficiencies and problems, and further solves the problem of cathetertip instability which may result in infusion of a toxic agentunintentionally into surrounding vessels while preventing reflux fromthe desired vessel into the surrounding vessels and tissues even whenthe catheter tip is stable and other factors cause the toxic substanceto reflux.

This Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description of the Invention, and nolimitation as to the scope of the present disclosure is intended byeither the inclusion or non-inclusion of elements, components, etc. inthis Summary of the Invention. Additional aspects of the presentdisclosure will become more readily apparent from the DetailedDescription, particularly when taken together with the drawings.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.However, the Detailed Description of the Invention, the drawing figures,and the exemplary claim set forth herein, taken in conjunction with thisSummary of the Invention, define the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. Further, the drawings of the devicedo not detail all features of the device, and do not show the entiredevice, for example some drawings only detail the device end, and notthe entire device length. Similar, some drawings do not detail theentire length of the channel involved, for example do not show theentire blood vessel length. It should be understood, of course, that thedisclosure is not necessarily limited to the particular embodimentsillustrated herein.

FIG. 1 schematically illustrates patient anatomy to include surgicalpoints of interest;

FIG. 2 schematically illustrates patient anatomy of the branches of theceliac axis;

FIG. 3 provides a side view of one embodiment of the device including adistal portion fitted with an inner sheath, and outer sheath, a hub, andlocking mechanism;

FIG. 4A is a cross sectional view of the distal tip of the device, theembodiment having fitted with an inner sheath, outer sheath, andundeployed expansile anchor;

FIG. 4B is a cross sectional view of the distal tip of the device ofFIG. 4A inserted within a vessel of a patient and the embodiment havingan expansile anchor deployed, showing flow through the center of thedevice and around the exterior of the device through the expansileanchor;

FIG. 4C is a perspective view of the distal tip of the device of FIG. 4Ainserted within a vessel of a patient and with the expansile anchordeployed;

FIG. 4D is a perspective view of the distal tip of the device of FIG. 4Ainserted within a vessel of a patient and with the expansile anchorundeployed;

FIG. 4E is a cross-sectional, perspective view of the distal tip of thedevice of FIG. 4A inserted within a vessel of a patient and with theexpansile anchor deployed;

FIG. 4F is a cross-sectional, perspective view of the distal tip of thedevice of FIG. 4A inserted within a vessel of a patient and with theexpansile anchor undeployed;

FIG. 4G is a perspective view of the distal tip of the device of FIG. 4Ainserted within a vessel of a patient and with the expansile anchordeployed;

FIG. 4H is a perspective view of the distal tip of the device of FIG. 4Ainserted within a vessel of a patient and with the expansile anchorundeployed;

FIG. 4I is a cross-sectional, perspective view of the distal tip of thedevice of FIG. 4A inserted within a vessel of a patient and with theexpansile anchor deployed;

FIG. 4J is a cross-sectional, perspective view of the distal tip of thedevice of FIG. 4A inserted within a vessel of a patient and with theexpansile anchor undeployed;

FIG. 5A is a cross-sectional, perspective view of the distal tip of anembodiment of the device inserted within a vessel of a patient, theembodiment having an expansile anchor deployed, and with flap mechanismdeployed;

FIG. 5B is a cross-sectional, perspective view of the distal tip of anembodiment of the device inserted within a vessel of a patient, theembodiment having an expansile anchor deployed, and with flap mechanismdeployed so as to conform to the deployed expansile anchor and thusprevent reflux;

FIG. 5C is a perspective view of the distal tip of an embodiment of thedevice of FIG. 5A inserted within a vessel of a patient, the embodimenthaving an expansile anchor deployed, and with flap mechanism deployed;

FIG. 5D is a perspective view of the distal tip of an embodiment of thedevice of FIG. 5B inserted within a vessel of a patient, the embodimenthaving an expansile anchor deployed, and with flap mechanism deployed soas to conform to the deployed expansile anchor and thus prevent reflux;

FIG. 5E is a cross-sectional, perspective view of the distal tip of anembodiment of the device of FIG. 5A inserted within a vessel of apatient, the embodiment having an expansile anchor deployed, and withflap mechanism deployed;

FIG. 5F is a cross-sectional, perspective view of the distal tip of anembodiment of the device of FIG. 5B inserted within a vessel of apatient, the embodiment having an expansile anchor deployed, and withflap mechanism deployed so as to conform to the deployed expansileanchor and thus prevent reflux;

FIG. 6 is a cross-sectional view of the distal tip of the deviceinserted within the vessel of a patient, the embodiment having anexpansile anchor deployed and an inner sheath that is moveable to adjustthe degree of cover of the expansile anchor;

FIG. 7A shows a front view of an elastomeric layer for an expansileanchor, the elastomeric layer having a one-way flap;

FIG. 7B shows a side view of the elastomeric layer of FIG. 7A takenalong line 7B-7B; and

FIG. 7C shows a side view of the elastomeric layer of FIG. 7A takenalong line 7C-7C.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a catheter with an anchoring device tostabilize the catheter tip when in use, such as when infusing,injecting, or delivering substances, devices or other catheters into apatient. Thus, for example, the foregoing description of the variousembodiments contemplates the use of an expansile member on the tip ofthe anchor catheter which is designed to anchor the tip and providestability while maintaining flow in the vessel, and a novelconfiguration of this member will limit and direct flow beyond thecatheter tip to obviate reflux. To achieve stability of the cathetertip, a porous tubular mesh braid is attached to the distal aspect of thecatheter in one embodiment. It may be a self expanding braid or it maybe controlled by actuator sheaths which will be subsequently described.The braid expands to the vessel wall and stabilizes the catheter tip bycontacting the wall, essentially anchoring it to the vessel wall by agentle annular force.

The following description will typically be with reference to specificstructural embodiments and methods. It is to be understood that there isno intention to limit the invention to the specifically disclosedembodiments and methods but that the invention may be practiced usingother features, elements, methods and embodiments. Preferred embodimentsare described to illustrate the present invention, not to limit itsscope, which is defined by the claims. Those of ordinary skill in theart will recognize a variety of equivalent variations on the descriptionthat follows. Like elements in various embodiments are commonly referredto with like reference numerals.

In order to provide greater clarity to the embodiments of the invention,a detailed description of the utility of the anchor catheter device ofthe current invention is first provided. An example medical proceduredetailed is that of infusing a substance into the liver, but one ofordinary skill in the art will appreciate the concepts are transportableto most any other artery. A utility is to anchor a guide catheter,delivery catheter and the like so that the tip of the anchored catheteris stable, does not move, and offers support for advancement of otherdevices, among other features.

Referring now to FIGS. 1-2 , the anatomy of a patient is shown.

In regard to FIG. 1 , patient anatomy is schematically illustrated toinclude surgical points of interest. FIG. 1 demonstrates organs andareas of interest within a patient 100, specifically the aorta 141,heart 142, right coronary artery 144 and left anterior descendingcoronary artery 143, right common carotid artery 147 and left commoncarotid artery 148 and other vessels, including the right 146 and left145 subclavian arteries, celiac artery trunk 161, superior mesentericartery 154, and right renal artery 156 and left renal artery 155. Ofparticular interest are the coronary arteries 143 and 144 and carotidarteries 147 and 148, which are frequently accessed for endovascularinterventions such as stenting and angioplasty. One can appreciate thetortuous path that a catheter must take to be placed at catheterpositioning point 149 in the left common carotid artery 147 prior to andduring a stent placement at stent placement point 150 in the left commoncarotid artery 148. To facilitate the placement of a catheter (notshown) and the delivery of a stent (not shown) at this location, a guidecatheter (not shown) is often utilized with the tip being placed atguide catheter positioning point 158. The aforementioned catheter andstent delivery device are placed coaxially within and through the guidecatheter with tip at guide catheter positioning point 158 and then theyare advanced to catheter positioning point 149 prior to theintervention. However, advancing the stent delivery device to catheterpositioning point 149 frequently causes the guide catheter to back outof the origin of the left common carotid artery 148 and into theascending aorta 141 preventing the proper placement of the catheter andstent delivery device at catheter positioning point 149. Even if thestent delivery catheter is successfully delivered to catheterpositioning point 149, attempts to advance it through a stenotic lesionof stent placement point 150 will cause the guide catheter to becomedislodged from its guide catheter positioning point 158 in the proximalleft common carotid artery 148. This will necessitate repeatedunsuccessful attempts to coax the stent delivery device across thelesion, a catheter exchange and time delays, prolonging the procedureand creating additional risk of stroke to the patient. As will bedemonstrated subsequently, the current invention will secure the guideanchor catheter 171 to a point in the proximal left common carotidartery 148 and overcome the technical problems caused by frequentlyencountered tortuous patient anatomy and narrowed stenotic lesions thatcreate resistance to the passage of guide wires and/or catheters.

Similarly, to access a point in the left anterior descending coronaryartery 143, a guide catheter (not shown) is used and the tip is placedwithin the left main coronary artery 159 with the stent deliverycatheter (not shown) placed coaxially though the guide catheter.Advancing a guide wire (not shown) or stent delivery catheter into thedistal left anterior descending coronary artery 143 through a stenosisat stenosis point 152 which provides resistance can obviously beproblematic because of the tortuous anatomy and the resistance caused bythe stenotic lesion. Analogous to the above description, the tortuosityand the resistance caused by the stenotic lesion will cause the guidecatheter to become dislodged from its purchase in the origin of the leftmain coronary artery 159. When the guide catheter becomes dislodged,there is no support to push the guide wire or stent delivery catheterthrough the stenotic lesion, and this necessitates multiple catheterand/or guide catheter exchanges, guide wire exchanges, furtherpre-dilatation of the lesion, and so forth that would not be necessaryif the guide catheter were secured and offered support to theadvancement of the guide wire or catheters through the stenotic lesion.

The same phenomenon of inability to properly access a vascular area orlesion occurs in many of the other arteries shown in FIG. 1 . One ofordinary skill in the art is familiar with the specific difficultiesinvolved in accessing individual arteries. These difficulties may occurwhen performing a vascular intervention such as angioplasty, stentplacement, or the like, and when placing a catheter at a specificlocation for infusing an agent or substance among other reasons.

Furthermore, crossing chronic total occlusions (CTO's) deserves specialmention as there is complete occlusion of the vascular lumen. Probingwith the guide wire through the “cap” of the occlusion, or the hardenedface of the occlusion, can be difficult with much resistance as there isno lumen. Typically, the guide wire causes the guide catheter orinterventional catheter to back out of its position within the arteryrather than exerting enough forward pressure to penetrate and passthrough this arterial cap. By anchoring the current device to thearterial wall, more forward pressure will be exerted and the CTO will bemore easily crossed. Moreover, the device of the current invention willcenter the catheter lumen, and hence the guide wire, in the center ofthe vessel. The penetration of the arterial cap will less likely resultin a subintimal passage of the guide wire than if done with aneccentrically placed guide wire. Therefore, the passage through the CTOwill be done more easily and within the correct channel than with priorart devices.

In regard to FIG. 2 , anatomy of the celiac axis is schematicallyillustrated to include surgical points of interest. FIG. 2 presents theceliac artery 160, including the celiac trunk 161, the splenic artery162, the left gastric artery 163 and the common hepatic artery 164.Further, the common hepatic artery 164 supplies the right gastric artery167, the gastroduodenal artery 166, and the proper hepatic artery 165.The infusion catheter is usually placed through a puncture in the commonfemoral artery (not shown) in the groin, through the celiac trunk 161and the common hepatic artery 164 and into the proper hepatic artery165. The tip must be placed proximal to the origins of the left hepaticartery 168 and the right hepatic artery 169 so that the infusedsubstance flows into each artery in generally the same concentration.The tip must be placed at approximately artery point 170 to accomplishthis. One can appreciate the tortuous path that the catheter must taketo reach this point from the groin especially considering the cathetermust traverse many different planes not shown in this two dimensionaldrawing. Since there is some inherent stiffness in the catheter toenable maneuverability given the tensile forces imparted to thecatheter, the multiple curving vessels causes some torque on the distalcatheter creating potential instability of the tip, especially when thecatheter is subjected to motion from breathing, arterial pulsations, orpatient movement. One can also readily appreciate the close proximity ofthe right gastric artery 167 and the gastroduodenal arteries 166 to theproper hepatic artery 165, and realize that only minimal movement of thecatheter tip may cause it to become dislodged from the rather shortproper hepatic artery 165, allowing a toxic agent to be inadvertentlyinfused into the left gastric 167 and gastroduodenal arteries 166 whichsupply the distal stomach, pylorus, duodenum, and pancreas or even moreproximal arteries and the aorta. In fact, frequently the distancebetween the origin of the proper hepatic artery 165 and the artery point170 proximal to the bifurcation of the proper hepatic artery 165 is onlytwo (2) centimeters or less. Infusing a toxic substance into this smalltarget area obviously can be risky not only from catheter movement, butalso just from reflux of the infused material proximally into the otherarteries, such as the gastroduodenal arteries 166, the right gastricartery 167 and left gastric artery 163, and the splenic artery 162, evenif the catheter were stable.

Referring now to FIGS. 3-6 , several embodiments of the presentinvention are shown.

In regard to FIG. 3 , an anchor catheter device 171 is shown comprisingan anchor catheter proximal tip 172, an anchor catheter distal tip 173,an outer sheath or tube 174 and an inner sheath or tube 175. Each of theanchor catheter proximal tip 172 and the anchor catheter distal tip 173form lumens. The device 171 has the general shape of a standardselective angiographic catheter used to access abdominal vesselsincluding the proper hepatic artery 165 of FIGS. 1 and 2 . The anchorcatheter device 171 is configured to include a housing having a hollowinterior, an open proximal end 172, a distal end or tip 173 and anaperture on a lateral side of the housing. A coupling element isprovided for connecting the distal end 173 of the catheter body to theproximal end of the housing. Various work elements or mechanisms aremounted and movably disposed at the anchor catheter distal tip 173 andconfigured in the housing and operative through the aperture. A workelement connector is disposed in a lumen of the catheter body,preferably the axial lumen, and has a distal end connected to the workelement. The proximal end of the connector is available at the proximalend of the catheter body for attachment to a device appropriate for theoperation of the work element.

FIG. 3 generally provides the embodiment of the anchor catheter device171 in one embodiment particularly suited to perform as an infusion ordelivery catheter. Alternatively it could represent a guide catheter toaccess the celiac trunk 161 of FIGS. 1 and 2 . The device 171 has thegeneral shape of a standard selective angiographic catheter used toaccess abdominal vessels including the proper hepatic artery 165 ofFIGS. 1 and 2 .

In the embodiment of FIG. 3 , the device 171 includes a lockingmechanism 176 rotatably or otherwise attached to the outer sheath 174which may be fixable to the distal aspect of a hub 178 of the device171. When an anchoring mechanism or work element, such as a braid, ofthe device 171 is expanded, the inner sheath 175 is advanced into andthrough the outer sheath 174 causing the locking mechanism 176 to engagethe distal aspect of the hub 178. The two components can be lockedtogether by turning them or by other means. The device 171 may beutilized alone or may be delivered through a guide catheter to theceliac axis. A companion guide catheter may in fact have the same orsimilar shape and features as the configuration demonstrated for thedevice 171 when used for infusion or delivery. A guide catheter, forexample, may be anchored in the proximal celiac axis, and the device 171would pass coaxially through the guide catheter to, for example, theartery point 170 of FIG. 2 . The device 171 may also be fitted with aguide catheter to thus operate as a substantially integrated unit ordevice.

In the embodiment of FIGS. 4A-J, a preferred embodiment of the device171 is provided in detail that comprises an expansile anchor 181mechanism or working element which may be controllably deployed within avessel wall 200 of a patient 100.

Referring now in detail to FIGS. 4A-B, cross-sectional views of ananchor catheter device 171 is provided with a distal tip 173 configuredwith an expansile anchor 181. When deployed, the expansile anchor 181imparts a minimal but effective level of axial force against thesurrounding vessel 200 of a patient 200 so as to stabilize the anchorcatheter device 171. The anchor catheter device 171 comprises an outersheath 174 coaxially placed over an inner sheath 175. The two sheathsare moveable relative to the each other serving to expand and collapsethe expansile anchor 181. FIG. 4A depicts the device 171 with theexpansile anchor 181 undeployed, a configuration utilized when thedevice is inserted into the patient 100. Further, FIG. 4A-B depict theexpansile anchor 181 configured as a mesh braid. When the braid isexpanded, as depicted in FIG. 4B, the inner sheath 175 is advanced intoand through the outer sheath 174 causing the expansile mesh braid 181 tocontrollably engage the vessel wall 200. Herein the terms “expansileanchor” and “mesh braid” and “braid” all reference the expansile anchormechanism 181. The expansile anchor mechanism 181 may be aself-expanding or it may be controlled by actuator sheaths which will besubsequently described. The braid 181 expands to the vessel wall 200 andstabilizes the catheter distal tip 173 by contacting the vessel wall200, essentially anchoring the device 171 to the vessel 200 wall by agentle annular force.

In regard to FIG. 4B, the expansile mesh braid 181 on the tip of thedevice 171 is designed to anchor the distal tip 173 and providestability while maintaining flow in the vessel 200, and further to limitand direct flow beyond the catheter distal tip 173 to obviate reflux.Medicament (or medical devices or implements such as stents) isdelivered to the patient 100 through the inner sheath 174 of the device171, as depicted by the center, left to right, arrow in the center ofthe device 171. In this manner, medicament flow is directed beyond thecatheter distal tip 173 and minimizes backflow or reflux of themedicament. Harmful effects of uncontrolled or errant reflux wasdiscussed in previously, and is to be avoided.

In the embodiment of the invention of FIGS. 4A-J, the expansile anchoror braid 181 of the device 171 is bonded to the distal ends of the innersheath or tube 175 and to the outer sheath or tube 174. FIGS. 4C-Jprovide perspective views of the distal tip of the device of FIGS. 4A-Bas inserted within a vessel 200 of a patient 100. FIGS. 4C, 4E, 4G, and41 depict the expansile anchor 181 deployed, while FIGS. 2D, 4F, 4H, and4J depict the expansile anchor 181 not deployed. The expansile anchorbraid 181 is collapsed (i.e. moved from deployed to not deployedposition) by withdrawing the inner sheath 175 with respect to the outersheath 174 and expanded (i.e. deployed) against the vessel wall 200 byadvancing the inner sheath member 175 with respect to the outer sheathmember 174. When the braid 181 is expanded against the vessel wall 200,the braid 181 will anchor the catheter tip 173 and prevent the cathetertip 173 from moving because of patient 100 movement, respiratorymovement, or just because of the torque caused by the circuitous pathtraversed from, for example, the femoral artery to the proper hepaticartery 165 of FIG. 2 . This will add significantly to the safety profileof the procedure. Moreover, an impermeable elastomeric membrane 183 maycover a portion of the mesh braid so that antegrade blood flow occursabout and beyond the catheter tip, but the flow is partially obstructedor limited. This would cause the pressure in the hepatic arteries 168and 169 of FIG. 2 , for example, distal to the catheter tip 173 to beless than the pressures proximal to the catheter tip 173, hence thelikelihood of any reflux of infused agent or medicament would bemarkedly diminished. The impermeable elastomeric membrane 183 may beplaced on or within the mesh braid 181 at any location to include nearthe inner sheath 175 or near the outer sheath 174 or in the middlebetween sheaths 174 and 175, but preferably only covering a portion ofthe braid 181 so that flow is maintained. In this embodiment of thedevice 171, the expansile anchor 181 comprises an impermeableelastomeric membrane portion 183 and a permeable mesh braid portion 182,thereby providing a level of controllability to the blood flow, toinclude the blood flow between the device 171 and the vessel wall 200.

In delivering drugs, embolics, or other substances to tumors withinorgans, it may be important to control the flow to that organ foranother reason. Usually the tumors within an organ are more vascularizedthan the normal tissue and flow is preferential to the tumors. This maycause greater blood flow in the artery serving the organ. By diminishingthe overall blood flow to the organ, one may create a condition in whichthere is a exaggerated disproportionate flow of blood to the tumor orfibroid as the more highly vascularized tumor will siphon the blood flowfrom the normal tissues. This will allow more of a chemotherapeuticagent, embolic agent, other drugs and materials to be delivered to thetumor than to the normal tissues from a more remote catheter tipposition within the main artery to the organ or a first branch of themain artery rather than a subselective or suprasubselective branch nearthe tumor. Hence control of the blood flow has advantages other thanpreventing reflux in that the agents to be delivered may be deliveredmore easily and timely.

In a preferred embodiment, the impermeable elastomeric membrane 183 isplaced on or within the expansile anchor mesh braid 181 away from thecatheter tip 173. This forces the blood to flow through the open portionof the braid 181 as demonstrated by the arrows of FIG. 4B and about andjust distal to the distal tip 173 of the anchor catheter device 173.This redirected flow insures enhanced admixing of the injected agent ormedicament with the flowing blood. This feature is particularlyimportant in the proper hepatic artery 165 of FIG. 2 which is a rathershort artery and it insures successful perfusion of both right and lefthepatic artery branches 167, 168 of FIG. 2 .

Therefore, by incorporating the expansile mesh braid 181 into thecatheter tip 173, as depicted in FIGS. 4A-J, the current inventionprovides stability of the anchor catheter device 171 preventing thedevice 171 from becoming dislodged from its position in, for example,the proper hepatic artery 165 of FIG. 2 , and provides for back flow orreflux prevention by partially occluding the vessel 200 while stillproviding for antegrade flow of blood that will carry the infused agentor medicament into, for example, the liver and to the tumor it isintended to treat. Enhanced admixing of the agent or medicament insuresproportionate delivery of the agent to the branching arteries,especially if the anchor catheter tip 173 is positioned in closeproximity to the arterial branches. Further, it is frequently desirableto place a catheter in close proximity to the arterial branches toprevent the reflux phenomenon described above, therefore this flowdirecting feature of the current invention device 171 is highlydesirable.

In a further embodiment based upon that depicted in FIGS. 4A-J, thecoating of the mesh braid 183 is placed in such a position that when thepressures distal to the tip 173 (i.e. to the right in, for example, FIG.4B) become close to or equivalent with the pressures proximal to the tip(i.e. to the left in FIG. 4B), the mesh braid 183 changes shape so thata further reduction in blood flow occurs through the permeable portionsof the tubular braid 183.

Referring now to FIGS. 5A-F, a further embodiment of the device 171 isprovided in detail that comprises an expansile anchor 181 mechanism orworking element which may be controllably deployed within a vessel wall200 of a patient 100, as well as a flap mechanism 190 with flapmechanism fluted-bell 192. This embodiment is similar to that of FIGS.4A-J, with the addition of the flap mechanism 190 and flap mechanismfluted-bell 192.

Referring now in detail to FIGS. 5A-F, perspective views are depicted ofthe anchor catheter device 171 as provided with a distal tip 173configured with an expansile anchor 181. When deployed, the expansileanchor 181 imparts a minimal but effective level of axial force againstthe surrounding vessel 200 of a patient 200 so as, to stabilize theanchor catheter device 171. The anchor catheter device 171 comprises anouter sheath 174 coaxially placed over an inner sheath 175. The twosheaths are moveable relative to the each other serving to expand andcollapse the expansile anchor 181. FIGS. 5A-F all depict the device 171with the expansile anchor 181 deployed as inserted within a vessel 200of a patient 100. To deploy the expansile anchor 181, the inner sheath175 is advanced into and through the outer sheath 174 causing theexpansile mesh braid 181 to controllably engage the vessel wall 200. Theexpansile anchor mechanism 181 may be a self-expanding or it may becontrolled by actuator sheaths which will be subsequently described. Thebraid 181 expands to the vessel wall 200 and stabilizes the catheterdistal tip 173 by contacting the vessel wall 200, essentially anchoringthe device 171 to the vessel 200 wall by a gentle annular force.

In the embodiment of the invention of FIGS. 5A-F, the expansile anchoror braid 181 of the device 171 is bonded to the distal ends of the innersheath or tube 175 and to the outer sheath or tube 174. The expansileanchor braid 181 is collapsed (i.e. moved from deployed to not deployedposition) by withdrawing the inner sheath 175 with respect to the outersheath 174 and expanded (i.e. deployed) against the vessel wall 200 byadvancing the inner sheath member 175 with respect to the outer sheathmember 174. Moreover, an impermeable elastomeric membrane 183 may covera portion of the mesh braid so that antegrade blood flow occurs aboutand beyond the catheter tip, but the flow is partially obstructed orlimited. This would cause the pressure in the hepatic arteries 168 and169 of FIG. 2 , for example, distal to the catheter tip 173 to be lessthan the pressures proximal to the catheter tip 173, hence thelikelihood of any reflux of infused agent or medicament would bemarkedly diminished. The impermeable elastomeric membrane 183 may beplaced on or within the mesh braid 181 at any location to include nearthe inner sheath 175 or near the outer sheath 174 or in the middlebetween sheaths 174 and 175, but preferably only covering a portion ofthe braid 181 so that flow is maintained. In this embodiment of thedevice 171, the expansile anchor 181 comprises an impermeableelastomeric membrane portion 183 and a permeable mesh braid portion 182,thereby providing a level of controllability to the blood flow, toinclude the blood flow between the device 171 and the vessel wall 200.In a preferred embodiment, the impermeable elastomeric membrane 183 isplaced on or within the expansile anchor mesh braid 181 away from thecatheter tip 173. This forces the blood to flow through the open portionof the braid 181 as demonstrated by the arrows of FIG. 4B and about andjust distal to the distal tip 173 of the anchor catheter device 173.This redirected flow insures enhanced admixing of the injected agent ormedicament with the flowing blood.

Further, in the embodiment of the invention of FIGS. 5A-F, a separateflap mechanism 190 is provided that allows forward flow but not reverseflow or reflux. The flap mechanism 190 extends from within the innersheath 175 in a generally fluted-shape that extends past or distally tothe distal tip of the device 173 such that when extended, it has minimalto no effect on the blood flow in the vessel 200, but when restedagainst the expansile braid 181, restricts or totally prevents bloodflow. The separate flap mechanism 190 may be controlled and positionedby movement of the inner sheath 175, by a guide wire, by an additionalinner sheath, or other means.

In another embodiment, to further prevent movement or migration of thedevice 171 during infusion, an attachment mechanism secured to thedevice 171 shaft at or near the skin insertion site may be provided.This attachment mechanism may vary in configuration from a sutureattached to the tissues, to a clip at the skin level, to an anchoringdevice, or any other means of preventing movement of the catheter.

In the embodiment of the invention of FIG. 6 , the expansile anchor 181of the anchor catheter device 171 is configured as a mesh braid, as inFIGS. 4A-J and 5A-F, yet is mounted solely to the inner sheath 175 andnot additionally mounted to the outer sheath 174. In this embodiment,the expansile anchor 181 is an extension of the distal aspect of theinner sheath 175. When undeployed, the expansile anchor braid 181 iswithin the lumen of the distal tip 173 of the device 171 and is internalto the outer sheath 174. The expansile anchor braid 181 is extended ordeployed by movement of the inner sheath 175 away from or distally tothe outer sheath 175 (as depicted in FIG. 6 ). The expansile anchorbraid 181 self-deploys as the inner sheath 175 is moved further awayfrom the outer sheath; the expansile anchor braid 181 deploys so as torest against the vessel wall 200 and impart a controlled axial forceagainst the vessel wall 200. The expansile anchor braid 181 isconfigured with a permeable mesh braid portion 182 and an impermeableelastomeric portion 183. To control blood flow and pressure distally,the outer sheath 174 is advanced over the permeable mesh braid portion182, therein covering at least a portion of the permeable mesh braidportion 182 and thus regulating or throttling blood flow. Thisembodiment may provide additional flexibility to the anchor catheterdevice 171.

It should be noted that the features of the embodiments of FIG. 3 ,FIGS. 4A-J, FIGS. 5A-F and FIG. 6 may be combined or adapted in anyconfiguration to form embodiments not explicitly depicted or described.For example, the flap mechanism 190 with or without flap mechanismfluted-bell 192, as depicted in FIGS. 5 a-f, may be fitted to theembodiment of the device 171 depicted in FIG. 3 , or to the embodimentof the device 171 depicted in FIG. 6 .

Furthermore, additional means of preventing reflux may comprise of smallflaps within the interstices of the braid. FIGS. 7A-7C demonstrate theseembodiments. The elastomer may be cut with a laser or other means sothat it creates an incision 210 and a one-way flap 201 that allowsantegrade flow but not retrograde flow as demonstrated in FIG. 7A. Theflap 201 may be any one of several shapes including the depictedhorseshoe shape, rectangular, elliptical, triangular, and the like.Braid filaments 202, 203, 204, 205 define the interstices 206 of thebraided structure 207. These interstices 206 comprise an elastomer 208that is bound to the braid filaments 202, 203, 204, and 205 as shown inFIGS. 7B and 7C. The elastomer 208 is cut on a bias as shown in FIGS. 7Band 7C so that the flap 201 may move or be deflected in only onedirection and will be prevented from moving in the opposite direction.Hence, with fluid flowing proximal to distal, the flap 201 will beoriented so that it may be displaced only distally. This will allowantegrade blood flow to proceed when the pressure proximally is greaterthan the pressure distally, but reverse blood flow will be prevented asthe flap 201 will seat because of the bias. Therefore, reflux will beprevented. The flap 201 may be constructed in other methods. One suchmethod may involve cutting the elastomer 208 immediately adjacent tothree of the braid filaments while leaving the elastomer 208 attached tothe fourth braid filament. Additional elastomer (not shown) may then beadded to the flap 201 so that the flap is relatively oversized comparedto the interstices 206. The oversized flap may be placed preferentiallyon the distal aspect or downstream side of the braid. This configurationwould also allow antegrade flow but prevent retrograde flow or refluxback through the device.

In use, having two means of controlling flow and preventing reflux aredesirable as controlling or throttling flow at high flow rates as is thecase during the majority of an embolization procedure with theconfiguration of FIG. 4 is very practical. When stasis in the vesseloccurs because of the embolized particles, however, the throttlingaction will not prevent reflux as there may exist equal pressuresproximally and distally. Any additional injection of material may causethe pressure distally to exceed the pressure proximally and causereflux. While the configuration illustrated in FIG. 5 may address thisissue, an alternative embodiment as shown in FIGS. 7A-7C will alsoprevent reflux by allowing only antegrade blood flow. In this example,the braided end may be utilized to restrict flow during most of theprocedure by exposing portions of the braid devoid of elastomer andthrottling flow as has been previously described. Once the flow distalto the catheter slows visibly, the portion of the braid comprising theelastomer is positioned so that flow is essentially occluded except forthe openings associated with the flaps described. Flow would only occurthrough those openings in an antegrade manner.

This novel method of controlling flow may be applied to other inventionsas well. In my U.S. Pat. No. 6,635,068, which is incorporated herein, Idescribe a three dimensional detachable vascular occluder which iscomprised of a braided structure covered with an elastomer. Applying theimprovements in the immediately preceding paragraphs to this device isfeasible and may be accomplished.

Simply removing the elastomer from a very limited number of intersticeswithin the impermeable section is also feasible and may be accomplished.In this configuration, the resultant holes or orifices present withinthe impermeable section would allow a minimal amount of blood flowthrough the detachable vascular occluder so that the occlusion wouldonly be partial. This configuration may be valuable where there is aneed to diminish the blood flow significantly without completelyoccluding the flow so that the viability of the organ can be maintained,but the limited blood flow as a result of this improved device improvesor alters the functionality of the organ. This configuration may beapplicable to the stomach to facilitate weight loss, to the prostate tolessen its size, to the spleen in cases of hypersplenism or trauma, orin other organs and vascular territories where limiting, but notcompletely occluding, the blood flow is desirable.

To further prevent movement or migration of the device 171 duringinfusion, an attachment mechanism secured to the device 171 shaft at ornear the skin insertion site may be provided. Such an attachmentmechanism may vary in configuration from a suture attached to thetissues, to a clip at the skin level, to an anchoring device, or anyother means of preventing movement of the catheter. One configuration ofthe attachment mechanism near the skin insertion site may take the formof the embodiments of FIG. 3 , FIGS. 4A-J, FIGS. 5A-F, or FIG. 6 . Theattachment mechanism would be placed coaxially over the outer sheath ofany of the embodiments and would be only a few centimeters in totallength instead of the elongated catheter configurations previouslydescribed. When the tip of the chosen embodiment was in correctposition, the slideable attachment mechanism would be moved to aposition just within the skin insertion site and expanded within thetract formed by the catheter insertion by moving the outer sheathrelative to the inner sheath as previously described. This expandedconfiguration within the tract or channel formed by the catheter wouldfix the catheter and prevent movement.

Another similar use may entail placing the attachment mechanism on along term central venous catheter which may be used for dialysis,plasmaphoresis, and long term drug administration. Usually these centralvenous catheters are tunneled through a soft tissue tract severalcentimeters from the puncture site of the vein. Typically they contain acuff of material on the outer portion of the catheter which resides inthe tract and promotes cellular ingrowth into the cuff to help anchorand stabilize the catheter preventing catheter movement and lesseningthe chance of infection. It takes weeks if not months for substantialcellular ingrowth to occur, and the cuffs placed within the tunneledtracts of the current devices are not particularly effective atanchoring the catheter or preventing infection at this time. Oneconfiguration of the current invention would solve these problems. Theanchoring mechanism of FIG. 3 , FIGS. 4A-J, FIGS. 5A-F, or FIG. 6 couldbe placed coaxially over the central venous catheter and either fixed toit in a position that would cause it to reside within the extravasculartunneled tract of the central venous catheter or it may be slideablealong the surface of the central venous catheter to a position near theskin exit site of the central venous catheter within the tunneled tractand fixed to the central venous catheter at that point by any one ofseveral means. After the tip of the central venous catheter ispositioned, the anchoring mechanism would be positioned within thetunneled tract and expanded as in the foregoing examples against themargins of the tunneled tract to anchor the central venous catheter. Thebraid in the prior examples may be completely or partially covered withan impermeable substance or with a partially permeable substance, or maycontain antibiotics or other substances to inhibit infections or theingress of bacteria into the tunneled tract. Moreover the anchoringmechanism may be comprised of materials or substances that promote orinhibit cellular ingrowth. Removing the catheters of the current artdevices is problematic after cellular ingrowth of the cuffs has occurredas prolonged dissection of the cuffs from the tunneled tract tissues isrequired. The current invention would provide an anchoring mechanism notrequiring cellular ingrowth and an effective barrier to the ingress ofbacteria without the need for cellular ingrowth. Hence it would beeffective immediately from the time it was inserted and deployed vs. theseveral weeks to months required by the current devices, and removingthe catheter for exchange or complete removal would be greatlysimplified.

In fact, the above embodiment may be used on any catheter, tube, needle,probe, or other device within a tract in the human body to anchor orsecure it into position within the channel or tract formed by theparticular device, including but not limited to nephrostomy, cystostomy,gastrostomy, thoracotomy tubes, drainage catheters, needles or probesfor biopsy or treatment, and the like. It may also be utilized todiminish the chance of infection within the tract.

While the detailed descriptions above are principally concerned with atubular mesh braid as the expansile anchor 181 element that secures thedevice tip 173 to the wall of the vessel 200 while preserving flowbeyond the tip 173, other expansile anchor 181 configurations thataccomplish the same action are also feasible, including, but not limitedto stent like structures, parallel wires, non parallel wires, spiralelements, circular elements, malecots, tubular elements, laser cutstructures, buddy wires, and any structure or component which expandsnear the distal tip of the catheter and secures it while preserving flowis included by this mention.

The methods of utilizing all of the above configurations are quitesimilar. In the case of infusion of a substance into the liver andrecovering the effluent venous blood, filtering out the toxic agent, andreturning it to the body as has been previously described, imagingstudies such as CT scans, MRI, or others are utilized to measure thedistance between the most cephalad placement of the venous recoverycatheter, whether it be the cavoatrial junction or thesupradiaphragmatic IVC, and a point just above the renal veins.Measurements are also taken of the dimensions of the IVC. An appropriatesized recovery device is chosen. A catheter is placed in the properhepatic artery from a femoral puncture for subsequent perfusion of theliver by a concentrated high dose substance. This infusion catheter isusually delivered to the celiac trunk by a guide catheter which may havea special shape for engaging the celiac axis or trunk. It may be theguide catheter described above or a standard guide catheter. In manycases, the anchor infusion catheter described above may be used as theinfusion catheter. It is advanced through the guide catheter, throughthe celiac axis or trunk, and through the common hepatic artery, and thetip placed in the proper hepatic artery. In the case of the anchorcatheter, the mesh anchor is deployed stabilizing the catheter tip. Themesh anchor may or may not comprise a partial elastomeric coating whichlimits flow past the catheter tip as described previously. The recoverydevice of the current invention, in one configuration or the other, isplaced in the IVC and deployed so that the isolation apparatus coversthe hepatic venous ostia and creates a hepatic venous effluentcollection chamber. Testing is done to determine if the placement isappropriate by injection of contrast in a retrograde manner through therecovery catheter and into the hepatic venous effluent collectionchamber, and demonstrating that there is no leakage from the isolatedsegment. Contrast is injected into the distal IVC to determine thatthere is good return through flow to the right atrium. Hepatic venouseffluent will be collected, and the hepatic arterial infusion will beginthrough the hepatic artery infusion catheter. The venous effluent willbe collected and pumped and filtered and returned as in the prior artdevices for a period of time. After the arterial infusion is complete,the infusion catheter will be removed. In the case of the anchorcatheter, the distal braid is collapsed by advancing the inner memberwith respect to the outer member. The venous effluent collection andtreatment will continue for a prescribed period to prevent any delayedwashout of the concentrated high dose substance from the liver into thesystemic circulation. After a period of time, the chosen recovery devicewill then be collapsed, retracted, and removed from the body.

As to the method of utilizing a guide catheter with or as an integratedcomponent of the current invention device 171, usually the guidecatheter is placed coaxially over a diagnostic catheter. The diagnosticcatheter is then utilized to catheterize the origin of the selectedvessel, whether it be a coronary artery, a carotid artery, the celiacartery, or any other selected artery. The guide catheter 171 of thecurrent invention is then advanced over the tip of the diagnosticcatheter to a point in the proximal selected artery. The anchor 181 ofthe current invention device 171 may then be deployed and the diagnosticcatheter removed. The interventional catheter, whether it be a stentdelivery catheter, an angioplasty catheter, atherectomy device, infusioncatheter, or other type of catheter, will be advanced coaxially throughthe guide catheter of the current invention. In the case of tortuousanatomy in the selected artery, the anchored guide catheter of thecurrent invention supports the advancement of the interventionalcatheter even down tortuous side branches and the like. This is ofimportance in accessing a point for infusion of a substance or foraccessing a lesion distally placed in the selected artery. In the caseof a stenotic lesion, the anchored guide catheter of the currentinvention supports the advancement of a guide wire through a narrowstenotic lesion, or even through a complete occlusion, and allowssubsequent passage of the interventional catheter through a narrowedstenotic lesion. Forward pressure on the catheter will not cause it todislodge the guide catheter of the current invention as that guidecatheter is anchored securely within the orifice of the vessel. Theproblems with the prior art guide catheters are hence obviated, thelesions treated with less effort, less time, less cost, and less risk tothe patient.

To provide further clarity to the Detailed Description provided hereinin the associated drawings, the following list of components andassociated numbering are provided as follows:

Reference No. Component 100 patient 141 aorta 142 heart 143 leftanterior descending coronary artery 144 right coronary artery 145 leftsubclavian arteries 146 right subclavian arteries 147 right commoncarotid artery 148 left common carotid artery 149 catheter positioningpoint 150 stent placement point 152 stenosis point 154 superiormesenteric artery 155 left renal artery 156 right renal artery 158 guidecatheter positioning point 159 left main coronary artery 160 celiacartery 161 celiac trunk 162 splenic artery 163 left gastric artery 164common hepatic artery 165 proper hepatic artery 166 gastroduodenalarteries 167 right gastric artery 168 left hepatic artery 169 righthepatic artery 170 artery point 171 anchor catheter device 172 anchorcatheter proximal tip 173 anchor catheter distal tip 174 outer sheath175 inner sheath 176 locking mechanism 178 hub 179 distal end of hub 181expansile anchor 182 permeable mesh braid 183 impermeable elastomericmembrane 190 flap mechanism 192 flap mechanism fluted-bell 200 vesselwall 201 one-way flap 202 braid filament 203 braid filament 204 braidfilament 205 braid filament 206 interstices 207 braided structure 208elastomer 210 incision

While various embodiment of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A medical device for delivery of one or more of medicaments, agents, catheters, or devices into a body channel, the medical device comprising: an outer sheath having a distal end; an inner sheath having a distal end, the inner sheath being axially translatable and fitting within the outer sheath; and an expansile anchor mechanism deployable between collapsed and expanded configurations by axially translating the inner sheath and the outer sheath relative to one another, wherein the expansile anchor mechanism comprises a fluid permeable section comprising a fluid permeable mesh configured to engage a wall of the body channel and exert a controlled axial force against the wall when in the expanded configuration, wherein the expansile anchor mechanism is configured to at least partially obstruct fluid flow in the body channel when in the expanded configuration within the body channel, and wherein the expansile anchor mechanism, when in the expanded configuration, comprises a channel therethrough, wherein the channel is in fluid communication with a lumen of the inner sheath and configured to deliver the one or more medicaments, agents, catheters, or devices into the body channel when the expansile anchor mechanism is in the expanded configuration.
 2. The device of claim 1, wherein the expansile anchor mechanism comprises a distal end coupled to the distal end of the outer sheath and a proximal end coupled to the distal end of the inner sheath.
 3. The device of claim 1, wherein the expansile anchor mechanism comprises a proximal end coupled to the distal end of the inner sheath and a free distal end, wherein the expansile anchor mechanism is self-expanding.
 4. The device of claim 1, wherein the expansile anchor mechanism comprises a tubular shape in the collapsed configuration and a non-tubular shape in the expanded configuration.
 5. The device of claim 4, wherein the non-tubular shape is a funnel shape, a conical shape, an umbrella shape, or a ring shape.
 6. The device of claim 1, wherein the mesh comprises two or more materials of variable strength.
 7. The device of claim 1, wherein the mesh comprises a fabric material.
 8. The device of claim 1, wherein the expansile anchor mechanism is configured to provide fluid flow distal to the distal end of the outer sheath.
 9. The device of claim 1, further comprising a locking mechanism operably coupled to the inner and outer sheaths and configured to lock the expansile anchor mechanism in the expanded configuration when the inner and outer sheaths are axially translated relative to one another to deploy the expansile anchor mechanism.
 10. A method of delivering of one or more of medicaments, agents, catheters, or devices into a body channel, the method comprising: advancing a medical device to a target site; expanding an expansile anchor mechanism of the medical device from a collapsed configuration to an expanded configuration at the target site, wherein expanding the expansile anchor mechanism comprises translating outer and inner sheaths of the medical device relative to one another to deploy the expansile anchor mechanism in the target site, and wherein the expansile anchor mechanism is configured to at least partially obstruct fluid flow in the body channel when in the expanded configuration within the body channel; exerting a controlled axial force against the wall of the body channel with the expansile anchor mechanism in the expanded configuration, wherein the expansile anchor mechanism comprises a fluid permeable section comprising a fluid permeable mesh; and delivering one or more medicaments, agents, catheters, or devices into the body channel through a channel in the expansile anchor mechanism, wherein the channel is in fluid communication with a lumen of the inner sheath.
 11. The method of claim 10, wherein the expansile anchor mechanism comprises a distal end coupled to the distal end of the outer sheath and a proximal end coupled to the distal end of the inner sheath.
 12. The method of claim 10, wherein the expansile anchor mechanism comprises a proximal end coupled to the distal end of the inner sheath and a free distal end, wherein the expansile anchor mechanism is self-expanding.
 13. The method of claim 10, wherein the expansile anchor mechanism comprises a tubular shape in the collapsed configuration and a non-tubular shape in the expanded configuration.
 14. The method of claim 13, wherein the non-tubular shape is a funnel shape, a conical shape, an umbrella shape, or a ring shape.
 15. The method of claim 10, wherein exerting the controlled axial force against the wall of the body channel anchors a distal end of the medical device in the body channel.
 16. The method of claim 10, wherein advancing the medical device comprises advancing the medical device coaxially over a guide wire, advancing the medical device coaxially over a diagnostic catheter, or advancing the medical device coaxially through a guide catheter.
 17. The method of claim 10, further comprising regulating or throttling fluid flow or reflux within the body channel by shifting the expansile anchor mechanism between the expanded configuration and a collapsed configuration.
 18. The method of claim 10, further comprising locking the expansile anchor mechanism in the expanded configuration while delivering the one or more medicaments, agents, catheters, or devices into the body channel.
 19. The method of claim 10, wherein said target site comprises one or more of a site proximal to one or more of a vessel occlusion, a vessel obstruction, a vessel stenosis, a vessel tortuosity, a vessel stenosis, a vessel lesion to be treated, a vessel clot, a tumor supplied by a vessel, an organ, an organ supplied by a vessel, or a proximal portion of a branch vessel.
 20. The method of claim 10, wherein expanding the expansile anchor mechanism into the expanded configuration centers the lumen of the inner sheath within the body channel. 